| Primary Device ID | 00810131881115 |
| NIH Device Record Key | f5ffb5fe-7b41-4de6-9aaa-b8218ddd2705 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GraftGun Universal Kit - IOSAL |
| Version Model Number | GG-U-1000-IB |
| Company DUNS | 004095409 |
| Company Name | SURGENTEC, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |